CSF biomarker variability in the Alzheimer's Association quality control program
| Autor: | Sabine Haustein, Eva Arkblad, Manfred Windisch, Walter Maetzler, Annette Spreer, Flora Berisha, Knudsen Cindy Søndersø, Hiroyuki Arai, Ralph Martin, Muriel Quillard, Marcel M. Verbeek, Lucilla Parnetti, Robert M. Umek, Aurélie Bedel, Silvana Archetti, Alberto Lleó, Marilyn S. Albert, László Vécsei, Mathias Jucker, Catherine Malaplate-Armand, Michael T. Heneka, Qiao-Xin Li, Daniela Galimberti, Karen H. Gylys, Xavier Parent, Igor Vostiar, Sebastiano Cavallaro, Silvana Gritti, Charlotte E. Teunissen, Ging-Yuek Robin Hsiung, Leslie M. Shaw, Roy B. Dyer, Daniele Bentue-Ferrer, Robert A. Rissman, Silvia Suardi, Ryozo Kuwano, Jose Luis Molinuevo, José Luis Molinuevo, C.E. Teunissen, Vara Luis Rello, Olivier Bousiges, Maria Berrocal Carrillo, Jordan Laser, Isabelle Quadrio, Neal Cutler, Stephan A. Käser, Marc Mercken, Sonia Chalbot, Niklas Mattsson, Giovanni B. Frisoni, Koen Poesen, Anne Fogli, Ulf Andreasson, Daniel Alcolea, Giuseppe Sancesario, Elisabeth Kapaki, Markus Otto, Aladro José A. Rojo, Khalid Iqbal, John Q. Trojanowski, Marinus A. Blankenstein, Jean-Louis Laplanche, Sergio Bernardini, Elisabetta Galloni, Inês Baldeiras, Hugo Vanderstichele, Kaj Blennow, Axel Regeniter, Colin L. Masters, Bradley T. Hyman, Holly Soares, Anna Antonell, Takeshi Iwatsubo, T. J. Montine, Steven J. Collins, Anne M. Fagan, Nick C. Fox, Daniel Kidd, Zdenek Rohan, Sebastiaan Engelborghs, Christin Sisowath, Péter Klivényi, Ronald C. Petersen, Bianca Van Broeck, Harald Hampel, Henrik Zetterberg, Hilkka Soininen, Maria C. Carrillo, Theresa Heath, Michael C. Camuso, Sanna-Kaisa Herukka, Johannes Schröder, Odile Delaroche, David M. Holtzman, William Nowatzke, Christian Humpel, Piotr Lewczuk, M.M. Verbeek, Piero Parchi, Foudil Lamari, D. Richard Lachno, Ales Bartos, Isabelle Cuvelier, Rik Vandenberghe, Sylvian Lehmann, Staffan Persson, Hanna Rosenmann, Manu Vandijck, Claude Jardel, Niels H. H. Heegaard, Anders Skinningsrud, Tiziana Casoli, Robert Martone, Dev Batish, Orestes Vicente Forlenza, Odete A. da Cruz e Silva, Diane Dufour-Rainfray |
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| Přispěvatelé: | N. Mattsson, U. Andreasson, S. Persson, M. C. Carrillo, S. Collin, S. Chalbot, N. Cutler, D. Dufour-Rainfray, A. M. Fagan, N. H. H, G. R. Hsiung, B. Hyman, K. Iqbal, D. R. Lachno, A. Lleó, P. Lewczuk, J. L. Molinuevo, P. Parchi, A. Regeniter, R. Rissman, H. Rosenmann, G. Sancesario, J. Schröder, L. M. Shaw, C. E. Teunissen, J. Q. Trojanowski, H. Vanderstichele, M. Vandijck, M. M. Verbeek, H. Zetterberg, K. Blennow, S. A. Käser, Alzheimer's Association QC Program Work Group, Laboratory Medicine, NCA - neurodegeneration |
| Rok vydání: | 2013 |
| Předmět: |
Oncology
Epidemiology standards Humans Laboratorie cerebrospinal fluid Chemistry standards Peptide Fragment Phosphorylation Societies Medical standards Enzyme-Linked Immunosorbent Assay Clinical neurochemistry medicine.diagnostic_test biology Settore BIO/12 Health Policy standards tau Protein Alzheimer's disease Patient management Chemistry Psychiatry and Mental health Cerebrospinal fluid Biomarker (medicine) Biological Markers Quality Control medicine.medical_specialty cerebrospinal fluid Biological Marker Reproducibility of Results Humans Alzheimer Disease tau Proteins Laboratories Hospital Peptide Fragments Amyloid beta-Peptides Chemistry Clinical Enzyme-Linked Immunosorbent Assay Amyloid beta DCN MP - Plasticity and memory cerebrospinal fluid/diagnosis Amyloid beta-Peptide cerebrospinal fluid Article Proficiency testing Hospital Clinical Cellular and Molecular Neuroscience Developmental Neuroscience Medical Internal medicine medicine DCN NN - Brain networks and neuronal communication cerebrospinal fluid Phosphorylation Quality Control Reproducibility of Results Societie Measurement variability business.industry Quality control medicine.disease Immunoassay Csf biomarkers Immunology biology.protein Neurology (clinical) Geriatrics and Gerontology Laboratories Societies business External assurance Biomarkers |
| Zdroj: | Alzheimers & Dementia r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau instname Alzheimer's & Dementia, 9, 3, pp. 251-61 Mattsson, N, Andreasson, U, Persson, S, Carrillo, M C, Collins, S, Chalbot, S, Cutler, N, Dufour-Rainfray, D, Fagan, A M, Heegaard, N H H, Hsiung, G Y R, Hyman, B, Iqbal, K, Lachno, D R, Lleo, A, Lewczuk, P, Molinuevo, J L, Parchi, P, Regeniter, A, Rissman, R, Rosenmann, H, Sancesario, G, Schroder, J, Shaw, L M, Teunissen, C E, Trojanowski, J Q, Vanderstichele, H, Vandijck, M, Verbeek, M M, Zetterberg, H, Blennow, K & Kaser, S A 2013, ' CSF biomarker variability in the Alzheimer's Association quality control program ', Alzheimers & Dementia, vol. 9, no. 3, pp. 251-261 . https://doi.org/10.1016/j.jalz.2013.01.010 Alzheimers & Dementia, 9(3), 251-261. Elsevier Alzheimer's & Dementia, 9, 251-61 |
| ISSN: | 1552-5260 |
| DOI: | 10.1016/j.jalz.2013.01.010 |
| Popis: | Background: The cerebrospinal fluid (CSF) biomarkers amyloid beta 1-42, total tau, and phosphorylated tau are used increasingly for Alzheimer's disease (AD) research and patient management. However, there are large variations in biomarker measurements among and within laboratories. Methods: Data from the first nine rounds of the Alzheimer's Association quality control program was used to define the extent and sources of analytical variability. In each round, three CSF samples prepared at the Clinical Neurochemistry Laboratory (Molndal, Sweden) were analyzed by single-analyte enzyme-linked immunosorbent assay (ELISA), a multiplexing xMAP assay, or an immunoassay with electrochemoluminescence detection. Results: A total of 84 laboratories participated. Coefficients of variation (CVs) between laboratories were around 20% to 30%; within-run CVs, less than 5% to 10%; and longitudinal within-laboratory CVs, 5% to 19%. Interestingly, longitudinal within-laboratory CV differed between biomarkers at individual laboratories, suggesting that a component of it was assay dependent. Variability between kit lots and between laboratories both had a major influence on amyloid beta 1-42 measurements, but for total tau and phosphorylated tau, between-kit lot effects were much less than between-laboratory effects. Despite the measurement variability, the between-laboratory consistency in classification of samples (using prehoc-derived cutoffs for AD) was high (>90% in 15 of 18 samples for ELISA and in 12 of 18 samples for xMAP). Conclusions: The overall variability remains too high to allow assignment of universal biomarker cutoff values for a specific intended use. Each laboratory must ensure longitudinal stability in its measurements and use internally qualified cutoff levels. Further standardization of laboratory procedures and improvement of kit performance will likely increase the usefulness of CSF AD biomarkers for researchers and clinicians. (C) 2013 The Alzheimer's Association. All rights reserved. |
| Databáze: | OpenAIRE |
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